41 Manufacturing Technicians jobs in Pittsburgh

Our People & Places Solutions business - reinforces our drive to improve the lives of people everywhere and epitomizes the "why" of what we do - the tremendous positive impact and value our solutions bring to our communities and society as a whole. From facilities delivering life-saving therapies and ensuring clean water to enabling the connection of people through all modes of transportation and providing access to technology - we're integrating a multitude of these solution elements to build the smart environments of tomorrow.
Start your Jacobs career with a company that inspires and empowers you to deliver your best work so you can evolve, grow and succeed - today and into tomorrow.
At Jacobs, we're not just building structures, we're helping our clients innovate and grow by designing, engineering, and executing the construction of their state-of-the-art facilities that are changing our world.
We're looking for a Quality Assurance Professional in Raleigh, NC?who is excited about working on projects that enable the heart of our clients' business. Join us and you'll have the chance to work on projects including state of the art industrial and commercial facilities. You will be recognized as an expert within the company. You'll be accountable for working with discipline subcontractors to ensure quality compliance, leading the development of Inspection Test Plans, and you will be responsible for Turn Over Package requirements and development. You'll also provide on-site assistance monitoring and visually inspecting material at receipt and before installation. Bring your curiosity, talent for multi-tasking?and collaboration, and extreme organizational skills and we'll help you grow, pursue and fulfill what drives you - so we can make big impacts on the world, together?
* Associate's degree or equivalent certified technical training
* At least 10 years of experience working in the QA/QC industry
Ideally, you'll also have:
* Strong communication skills both verbal and written
* Strong analytical and problem-solving skills
* Forward thinking, eager to learn best practices, and contribute with innovative ideas
* Displayed ability to learn quickly and driven to broaden knowledge base
* Ability to work effectively in a variety of teams, including multi-disciplinary teams
* Passion for buildings and construction
* Pharma experience
Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. Learn more about your rights under Federal EEO laws and supplemental language.

**Quality Control Chemist II**
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for inhalers and Nasal Sprays.
Catalent Pharma Solutions is Morrisville, NC is hiring a Quality Control Chemist II. The Quality Control Chemist II will independently perform work using a variety of methodology. Experience in a variety of analytical techniques and instrumentation is required. These may include compendial testing, identification techniques (i.e. FTIR), chromatography, among others. The Quality Control Chemist II will perform scientific analysis of data and draw reasonable conclusions, follow established methods and protocols, perform initial troubleshooting and investigations as needed, demonstrate leadership skills regarding guiding and training less experienced colleagues and comply with the company safety and operational requirements and procedures requirements.
This is a full-time, salaried role. The core hours are Monday - Friday 8:00AM - 5:00PM
This position is 100% on-site at the Morrisville site.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
**The Role:**
+ Execute laboratory activities according in compliance with safety, quality, and regulatory standards. (e.g., GMP, GLP, ICH guidelines)
+ Perform secondary review of analytical data generated by peers.
+ Assist laboratory technicians as needed with regards to training, scheduling, and troubleshooting.
+ Support drafting/reviewing of validation protocols, reports, investigations, or other technical documentation.
+ Participate in laboratory improvement projects as assigned.
+ Perform all other duties as assigned.
**The Candidate:**
+ Master's degree in scientific or engineering field and 1+ years related experience (or) Bachelor's degree in scientific or engineering field and 3+ years related experience (or) Associate's degree in scientific or engineering field and 6+ years related experience required.
+ Experience in testing in a GMP/GXP environment. Includes an understanding of good documentation skills, data integrity, and compliance.
+ Familiar with compendial testing including USP, EP, and JP compendia.
+ Able to organize workload and complete all required assignments in a timely manner.
+ Ability to interpret scientific data and form conclusions as needed and perform critical, scientific analysis of data as needed
+ Familiar with or able to learn a variety of analytical instrumentation including operation, maintenance, and troubleshooting.
+ Identify and participate in laboratory improvement projects.
+ Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds. Specific vision requirements including reading of written documents and the use of computer monitor screen frequently
**Why you should join Catalent:**
+ Defined career path and annual performance review and feedback process
+ Diverse, inclusive culture
+ Positive working environment focusing on continually improving processes to remain innovative
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
+ 152 Hours + 8 paid holidays
+ Several Employee Resource Groups focusing on D&I
+ Dynamic, fast-paced work environment
+ Community engagement and green initiatives
+ Generous 401K match
+ Company match on donations to organizations
+ Medical, dental and vision benefits effective day one of employment
+ Tuition Reimbursement - Let us help you finish your degree or start a new degree!
+ WellHub program to promote overall physical wellness
+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .

Our client, a leading pharmaceutical company dedicated to advancing healthcare, is seeking a meticulous and detail-oriented Pharmaceutical Quality Control Analyst for their facility in Raleigh, North Carolina, US . This critical role ensures the quality, safety, and efficacy of pharmaceutical products by performing rigorous analytical testing and adhering to strict regulatory guidelines. The ideal candidate will possess a strong background in analytical chemistry, experience with pharmaceutical quality control procedures, and a thorough understanding of Good Manufacturing Practices (GMP). Responsibilities include conducting various laboratory tests on raw materials, in-process samples, and finished products using techniques such as HPLC, GC, UV-Vis spectroscopy, and titration. You will be responsible for preparing reagents, maintaining laboratory equipment, documenting all testing procedures and results accurately, and investigating any out-of-specification (OOS) results. Collaboration with R&D, manufacturing, and regulatory affairs departments is integral to this role. A commitment to maintaining the highest standards of quality and compliance is paramount.

Key Responsibilities:

• Perform analytical testing on raw materials, in-process samples, and finished pharmaceutical products.
• Utilize various analytical techniques including HPLC, GC, UV-Vis, FTIR, and wet chemistry.
• Prepare reagents, standards, and sample solutions.
• Operate and maintain laboratory equipment, ensuring calibration and functionality.
• Document all testing procedures, results, and observations accurately in compliance with GMP.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results and determine root causes.
• Develop and validate new analytical methods as required.
• Review and approve test data and batch records.
• Ensure compliance with all relevant regulatory guidelines (e.g., FDA, ICH).
• Maintain a clean and organized laboratory environment.
• Collaborate with manufacturing, R&D, and regulatory teams to resolve quality issues.
• Participate in internal and external audits.

Qualifications:

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific field.
• Minimum of 3 years of experience in pharmaceutical quality control or analytical testing.
• Proficiency in analytical techniques relevant to pharmaceutical analysis (HPLC, GC, spectroscopy).
• Strong understanding of GMP, regulatory requirements, and quality assurance principles.
• Excellent documentation and record-keeping skills.
• Proficiency in Microsoft Office Suite and laboratory information management systems (LIMS).
• Strong analytical and problem-solving abilities.
• Good communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Attention to detail and commitment to accuracy.

Join a vital team contributing to the development and production of life-saving medications in Raleigh, North Carolina, US .

Overview

This is a hybrid role with the expectation that time working will regularly take place inside and outside of our company office located at 100 East Tryon Rd, Raleigh, NC 27603.

This position is responsible for ensuring the Business & Commercial Credit Resolution Group operates continuously in Compliance with Bank policy and with the Departments Standard Operating Procedural Manual. To achieve continual compliance, this individual is a subject matter expert with Business & Commercial CRG's complex operations, and via frequent testing and monitoring; this individual will ensure the Departments Risk Control Self Assessments, Procedures, Compliance Controls, Quality Assurance / Quality Controls are current and aligned. The individual will be a central point of contact for Internal and External Audits, Compliance Reviews, Loan Reviews, etc. The individual will interact frequently with Department Leaders / Executives and Leaders / Executives from other Business units. They will coach and guide the teams on highly complex risk related issues and should have governance, risk and compliance related experience.

Responsibilities

• Quality Control Oversight - Serves as subject matter expert (SME) providing guidance and process coaching to business units to ensure appropriate collaboration between the business unit and risk management organization. Ensures Business & Commercial Credit Resolution operates continuously in Compliance with Bank policy and with the Departments Standard Operating Procedural Manual. Focused on frequent testing and monitoring; this individual will ensure the Departments Risk Control Self Assessments, Procedures, Compliance Controls, Quality Assurance / Quality Controls, Business & Continuity Plans, are current and aligned.
• Remediation - Analyzes test results and collaborates with Leadership to identify root cause and appropriate remediation plan according to the risk. Facilitates completion of plans.
• Reporting - Provides results to Department Managers and Senior Leaders with regular cadence. Escalates as required when results are not in line with established tolerances. Provides monthly and quarterly reporting.
• Business Support - Maintains Risk Control Self-Assessment (RCSA) and updates Archer with required information. Maintains procedures and ensures annual procedure review and updates occur, ensures material procedural changes are documented, and communication and attestation by team takes place. Collaborates with team in the development of job aids and other training materials as needed. Performs other tasks as related to ensuring compliance, upholding quality standards and mitigating possible risk for the bank and all other duties as assigned. This seasoned individual will be a critical point of contact for the Business Unit during Internal & External Audits, Exams, RCSA refresh, BCP refresh, QA/QC, etc.

#LI-JL1

Qualifications

Bachelor's Degree and 8 years of experience in Regulatory Compliance, Bank Internal Audit, or Risk Management within a credit administration area OR High School Diploma or GED and 12 years of experience in Regulatory Compliance, Bank Internal Audit, Risk Managementwithin a credit administration area

Preferred Area of Experience:

Regulatory Compliance with a Bank

Previous Participation in Bank Audits

Familiarity with Risk Control Statements

Prior involvement with Business Continuity Planning

Prior involvement with Quality Assurance / Quality Control tests

Risk and/ or Audit experience with Credit Administration within a Bank

Quality Assurance / Quality Control testing experience within a Bank's Credit Administration Department

Knowledge of Bank Audits or Exams

Knowledge of Bank Compliance Regulations and Risk Control Statements relating to Credit Risk

Knowledge of Special Assets and/or Credit Administration Operations

Large Financial Institutional experience a plus

Benefits are an integral part of total rewards and First Citizens Bank is committed to providing a competitive, thoughtfully designed and quality benefits program to meet the needs of our associates. More information can be found at

#J-18808-Ljbffr

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**Primary Responsibilities:**
+ **Participate in the development and review of the Clinical SOPs, Regulatory documents and Study Plans**
+ Participate in the Clinical SOPs periodic reviews as well as in the creation of new procedures
+ Participate in the study plans reviews
+ Participate in the review of Regulatory Documents (Clinical Study Protocol, Investigators Brochure, Informed Consent Form, Clinica Study Report)
+ **Provide quality oversight on the conduct of the clinical studies**
+ Perform periodic quality reviews of the critical clinical procedures on the different clinical studies
+ Interact with Drug Development department to provide guidance and consultancy to resolve compliance issues
+ Coordinate the management of study, internal and vendor deviations
+ Participate in the review of critical protocol deviations and Serious Breaches
+ Participate in project team internal meetings providing information about quality metrics of studies
+ **Collaborate in the development of the Quality Risk Management Assessment of the different clinical studies**
+ Initiate the Quality Risk Assessment for every clinical study
+ **Qualification and periodic assessment of clinical and pharmacovigilance vendors participating in the clinical studies**
+ Perform a quality assessment (including a risk assessment) of all the vendors selected as candidates to participate in the clinical studies
+ Qualify the clinical vendors before their participation in the clinical studies and re-qualify them when applicable
+ Perform an annual assessment of the performance and compliance of the vendors participating in the clinical studies
**Requirements:**
+ Life Sciences Degree.
+ A minimum of 5 years in a similar role or provide experience in Quality and Clinical Trials.
+ Ability and willingness to travel.
+ Ability to work both in a team and independently.
+ Ability to meet deadlines, multitasks, and prioritize based on study needs.
+ Ability to works on assignments with a diverse scope.
+ Ability to work with a very limited direct supervision.
+ Advanced knowledge of ICH/GCP Guideline.
+ Advanced knowledge of electronic data capture (EDC) systems.
+ Advanced knowledge of medical terminology.
+ Advanced knowledge of the therapeutic areas assigned.
+ Routinely demonstrates mastery of technical skills
**Occupational Demands Form:**
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
Learn more about Grifols ( ID:** 527630
**Type:** Regular Full-Time
**Job Category:** Quality

**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Amgen, one of the world's leading biotechnology companies, is investing $550 million to build a new multi-product drug substance bio manufacturing facility in Holly Springs, North Carolina, a bio manufacturing "hub" known for their life sciences industry. The new plant will combine two production formats, traditional stainless-steel fed-batch and single-use technology. This combination of capabilities is an approach that Amgen calls "FleX Batch" manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgen's plan to be carbon neutral by 2027.
The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities and office space. Amgen is targeting 2024 for site completion.
Senior Manager Quality Control Support
**What you will do**
Let's do this. Let's change the world. In this vital role, Amgen is seeking a Senior Manager of Quality Control Support for our state-of-the-art manufacturing facility in Holly Springs, North Carolina. This leader will be responsible for overseeing key support functions within the QC organization, including laboratory systems, compliance, document management, sample lifecycle coordination, and continuous improvement initiatives. The role ensures alignment with cGMP standards, regulatory expectations, and Amgen's global quality systems.
**Strategic Leadership**
+ Lead and develop a high-performing QC support team with expertise in lab operations, documentation, and compliance systems.
+ Drive alignment between site QC operations and global Amgen quality policies and procedures.
**Quality Systems and Compliance**
+ Ensure QC operations maintain inspection readiness at all times.
+ Own and oversee laboratory deviation investigations, CAPA management, change control, and document lifecycle.
**Operational Support and Optimization**
+ Oversee implementation and maintenance of LIMS, Empower, and other QC systems.
+ Manage QC scheduling, sample logistics, and coordination with internal/external stakeholders.
+ Lead and support digital and lean initiatives to improve lab efficiency, throughput, and compliance.
**Talent Development and Cross-functional Engagement**
+ Recruit, mentor, and develop team members to build a robust talent pipeline.
+ Partner with Quality Assurance, Analytical Sciences, Manufacturing, and Regulatory to ensure seamless quality operations.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Senior Manager Quality Control Support we seek is a dynamic, resilient, flexible, and driven individual with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 12 years of Quality Analytical testing experience OR
+ Associate's degree and 10 years of Quality Analytical testing experience OR
+ Bachelor's degree and 8 years of Quality Analytical testing experience OR
+ Master's degree and 6 years of Quality Analytical testing experience OR
+ Doctorate degree and 2 years of Quality Analytical testing experience
**And**
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
**Preferred Qualifications:**
+ Master's degree or higher in a scientific or quality-related discipline
+ Experience in new facility start-up or tech transfer projects
+ Expertise in global regulatory requirements (FDA, EMA, etc.)
+ Strong background in laboratory compliance, LIMS, LMES, CIMS, Veeva and Trackwise systems
+ Lean Six Sigma or continuous improvement certification
+ Exceptional communication, leadership, and problem-solving skills
+ 2+ years of management experience at a senior level
+ Strong Leadership, Collaboration and Communication skills
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Associate Quality Control Support -Stability

What you will do

Let's do this. Let's change the world. In this vital role, you will be responsible for supporting the site Stability team QC start up and operations. Responsibilities will include writing procedures and reports and executing activities to support stability related initial lab equipment installation, qualification, and validation, and establishment of the stability laboratories. Role may involve travel to support method or knowledge transfers. The Senior Associate QC Stability will report directly to the Director of Quality Control. This individual will act as the site subject matter expert for the Stability program. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.

Under minimal supervision, the successful candidate will support the startup of the QC organization by:

• Drive implementation of Stability Program at ANC by establishing site specific processes and procedures, ensuring alignment with Amgen's Global Stability Program Strategy

• ?Manage clinical/commercial stability products, encompassing drug substance intermediates and drug substance for clinical/commercial programs

• Manage Stability Requests with Global Stability Coordinators and Product Quality Leads

• Ensure proper storage conditions for the ANC QC Stability Program maintaining sample integrity, including availability of back-up CTCs and appropriate segregation for all stability studies

• Ensure Stability Samples are processed in a timely manner and placed on stability according to the approved Stability Protocol

• Ensure stability studies are initiated within protocol timelines?

• Work collaboratively with site teams

• Ensure stability program is adherent to all cGMP regulations

• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.

• Support routine activities over the weekends and public holidays as required.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is an effective leader with these qualifications.

Basic Qualifications:

• High School/GED + 4 years of Quality work experience OR

• Associate's + 2 years of Quality work experience OR

• Bachelor's + 6 months of Quality work experience OR

• Master's

Preferred Qualifications:

• Degree in a related scientific field such as Chemistry, Microbiology, Molecular Biology, Physics or Engineering.

• 3-5 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.

• Solid understanding of aseptic technique.

• Proficient in the use of Veeva and Trackwise systems

• Experience in a lead role, providing guidance to team members.

• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discover.

• Strong knowledge of aseptic technique.

• Proficient in the use of LIMS & LMES/CIMS.

• Strong written and verbal communication skills including technical writing and presentation.

• Familiar with authoring or owning change control records.

• Experience with equipment and method validation, verification, and transfer including the change control process.

• Interact effectively with variety of communication and working styles and ability to work well in teams.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job Details

Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Associate Quality Control Support -Stability

What you will do

Lets do this. Lets change the world. In this vital role, you will be responsible for supporting the site Stability team QC start up and operations. Responsibilities will include writing procedures and reports and executing activities to support stability related initial lab equipment installation, qualification, and validation, and establishment of the stability laboratories. Role may involve travel to support method or knowledge transfers. The Senior Associate QC Stability will report directly to the Director of Quality Control. This individual will act as the site subject matter expert for the Stability program. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.

Under minimal supervision, the successful candidate will support the startup of the QC organization by:

• Drive implementation of Stability Program at ANC by establishing site specific processes and procedures, ensuring alignment with Amgen's Global Stability Program Strategy

• Manage clinical/commercial stability products, encompassing drug substance intermediates and drug substance for clinical/commercial programs

• Manage Stability Requests with Global Stability Coordinators and Product Quality Leads

• Ensure proper storage conditions for the ANC QC Stability Program maintaining sample integrity, including availability of back-up CTCs and appropriate segregation for all stability studies

• Ensure Stability Samples are processed in a timely manner and placed on stability according to the approved Stability Protocol

• Ensure stability studies are initiated within protocol timelines

• Work collaboratively with site teams

• Ensure stability program is adherent to all cGMP regulations

• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.

• Support routine activities over the weekends and public holidays as required.

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is an effective leader with these qualifications.

Basic Qualifications:

• High School/GED + 4 years of Quality work experience OR
• Associates + 2 years of Quality work experience OR
• Bachelors + 6 months of Quality work experience OR
• Master's

Preferred Qualifications:

• Degree in a related scientific field such as Chemistry, Microbiology, Molecular Biology, Physics or Engineering.
• 3-5 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Solid understanding of aseptic technique.
• Proficient in the use of Veeva and Trackwise systems
• Experience in a lead role, providing guidance to team members.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discover.
• Strong knowledge of aseptic technique.
• Proficient in the use of LIMS & LMES/CIMS.
• Strong written and verbal communication skills including technical writing and presentation.
• Familiar with authoring or owning change control records.
• Experience with equipment and method validation, verification, and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.

What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Senior Associate Quality Control Support -Stability**
**What you will do**
Let's do this. Let's change the world. In this vital role, you will be responsible for supporting the site Stability team QC start up and operations. Responsibilities will include writing procedures and reports and executing activities to support stability related initial lab equipment installation, qualification, and validation, and establishment of the stability laboratories. Role may involve travel to support method or knowledge transfers. The Senior Associate QC Stability will report directly to the Director of Quality Control. This individual will act as the site subject matter expert for the Stability program. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.
Under minimal supervision, the successful candidate will support the startup of the QC organization by:
+ Drive implementation of Stability Program at ANC by establishing site specific processes and procedures, ensuring alignment with Amgen's Global Stability Program Strategy
+ ?Manage clinical/commercial stability products, encompassing drug substance intermediates and drug substance for clinical/commercial programs
+ Manage Stability Requests with Global Stability Coordinators and Product Quality Leads
+ Ensure proper storage conditions for the ANC QC Stability Program maintaining sample integrity, including availability of back-up CTCs and appropriate segregation for all stability studies
+ Ensure Stability Samples are processed in a timely manner and placed on stability according to the approved Stability Protocol
+ Ensure stability studies are initiated within protocol timelines?
+ Work collaboratively with site teams
+ Ensure stability program is adherent to all cGMP regulations
+ Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
+ Support routine activities over the weekends and public holidays as required.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is an effective leader with these qualifications.
**Basic Qualifications:**
+ High School/GED + 4 years of Quality work experience OR
+ Associate's + 2 years of Quality work experience OR
+ Bachelor's + 6 months of Quality work experience OR
+ Master's
**Preferred Qualifications:**
+ Degree in a related scientific field such as Chemistry, Microbiology, Molecular Biology, Physics or Engineering.
+ 3-5 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
+ Solid understanding of aseptic technique.
+ Proficient in the use of Veeva and Trackwise systems
+ Experience in a lead role, providing guidance to team members.
+ Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discover.
+ Strong knowledge of aseptic technique.
+ Proficient in the use of LIMS & LMES/CIMS.
+ Strong written and verbal communication skills including technical writing and presentation.
+ Familiar with authoring or owning change control records.
+ Experience with equipment and method validation, verification, and transfer including the change control process.
+ Interact effectively with variety of communication and working styles and ability to work well in teams.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.